Effects of OMT on Interoception

NCT ID: NCT02464475

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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OMT

Group Type EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type OTHER

Sham

Group Type SHAM_COMPARATOR

sham osteopathic treatment

Intervention Type OTHER

Interventions

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osteopathic manipulative treatment

Intervention Type OTHER

sham osteopathic treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* chronic low back pain
* written informed consent signed

Exclusion Criteria

* congenital disease
* acute pain
* subject below 30 and above 50
* co-morbidities associated with low back pain
* surgical patients
* cardio-vascular, respiratory, gastro-enteric disease
* obese subjects
* diabetics
* dizziness
* subjects into pharmacological prophylaxis
* drug addicted subjects
* subjects undergoing physiotherapy
* subjects with experience in osteopathic treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chieti

OTHER

Sponsor Role collaborator

Come Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Francesco Cerritelli

DO, MS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Cerritelli, MS, DO

Role: PRINCIPAL_INVESTIGATOR

University of Chieti-Pescara

Locations

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University of Chieti-Pescara

Chieti, , Italy

Site Status

Countries

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Italy

Other Identifiers

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InterOST

Identifier Type: -

Identifier Source: org_study_id

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